Prospective rAndomized sTudy efficaCy tHree-dimensional rEconstructions Segmentectomy (PATCHES)

Ospedale Centrale Bolzano

Status: Not yet enrolling

Conditions: Lung; Node; Lung Cancer

Treatments: Diagnostic Test: CT scans 2D plus 3D Reconstruction; Diagnostic Test: CT scans 2D Reconstruction

Study type: Interventional

Funder types: Other

Identifiers

NCT05716815

1-2023

Details and patient eligibility

About

With this project we want to study the effectiveness of 3D reconstruction of preoperative CT to reduce operating times, blood loss and conversions after segmentectomy performed in thoracoscopy / robotics.

Full description

Pulmonary segmentectomy is the surgery of first choice in malignant lung tumors with a diameter <2 cm in diameter. Patients who are candidates for this type of treatment perform usually a preoperative CT scan with two-dimensional reconstructions (2D: axial, coronary and sagittal). Today it is possible to perform a preoperative three-dimensional reconstruction (3D: volume rendering) of the vessels and bronchi using special software.

Objectives of the study is to analyze, in these patients, the benefits of 3D reconstruction of vessels and bronchi compared to 2D reconstruction, analyzing intra- and post-operative data.The study aims to randomize 288 patients over 36 months.

Study design: Prospective, randomized, controlled study. In 50% of patients the preoperative study of anatomical structures will be performed with the standard 2D method, in the remaining 50% with a 2D and 3D reconstruction. The assignment will take place through access to an online feature on the study website.

Evaluations and statistical methods The statistical analysis will be carried out using parametric and nonparametric descriptive, inferential statistical methods, while the main outcome will be carried out using the analysis of variance (ANOVA) and covariance (ANCOVA) techniques.

Ethical aspects. The study will be conducted in accordance with applicable current legislation. Approval by all relevant ethics committees will be required. Each patient will provide a written consent to participate in the study, after being properly informed.

Enrollment: 288 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Segmentectomy performed through a minimally invasive approach (VATS or RATS).
• Pathologically proven NSCLC on the resected specimen.
• Age ≥18
• Signed written informed consent

Exclusion criteria

• Prior homolateral cardiothoracic surgery.
• Allergy or any other contraindication to iodinated contrast media.
• Segmentectomy performed through an open approach (thoracotomy)
• Histology different than NSCLC.
• Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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288 participants in 2 patient groups

2D Reconstruction

Active Comparator group

Description:

Before minimally invasive lung segmentectomy, preoperative chest CT scans are processed and evaluated with multi-plane (2D) reconstructions, according to the usual center protocol.

Treatment:

Diagnostic Test: CT scans 2D Reconstruction

2D plus 3D Reconstruction

Experimental group

Description:

Before minimally invasive lung segmentectomy, preoperative chest CT scans are processed and evaluated with volume rendering (3D) reconstructions.

Treatment:

Diagnostic Test: CT scans 2D plus 3D Reconstruction